First Month of Shots Find No Safety Issues With Pfizer/BioNTech, Moderna Vaccines: US Data

(Reuters) – The two COVID-19 vaccines approved for use in the United States have reassuring safety profiles with no concerning new issues found in data collected from the first month of vaccinations, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday.

After administration of 13.8 million doses of the Pfizer/ BioNTech and Moderna Inc vaccines to the U.S. population, most reports indicated non-serious side effects of the type that had been expected, such as headaches and fatigue. No deaths have been attributed to the vaccines, the data showed.

The CDC collected data between Dec. 14, 2020 and Jan. 13, 2021 from both an existing national surveillance system for adverse events and its own safety monitoring system established for COVID-19 vaccines.

During that time, 6,994 reports of adverse events after vaccination were recorded in the national surveillance system with 90.8% of them classified as non-serious and 9.2% as serious.

Rare cases of anaphylaxis, a severe allergic reaction requiring medical attention, were reported with both vaccines at a rate of 4.5 cases per million doses administered, down from the agency’s previously reported rate of 5 per million doses administered.

“Healthcare providers and vaccine recipients can be reassured about the safety of Pfizer and Moderna COVID-19 vaccines,” the CDC said in its Morbidity and Mortality Weekly Report.

A total of 113 deaths were reported and available information, including from death certificates and autopsy reports, found no causal link between COVID-19 vaccination and fatalities, CDC said.

SOURCE: MMWR, online February 19, 2020.

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